Zemdri

Zemdri is a prescription medication used to treat complicated urinary tract infections (cUTI), including pyelonephritis (severe kidney infection) caused by certain bacteria, in patients 18 years of age or older.

Zemdri belongs to a group of antibiotic drugs called aminoglycosides. It works by inhibiting protein synthesis in susceptible bacteria.

This medication comes in an injectable form to be given directly into a vein by a healthcare professional.

Common side effects of Zemdri include diarrhea, headache and nausea.

Zemdri is a prescription medication indicated in patients 18 years of age or older for the treatment of complicated urinary tract infections, including pyelonephritis (severe kidney infection) caused by the following bacteria: E. coli, K. pneumoniae, P. mirabilis and E. cloacae.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Zemdri. See the “Zemdri Precautions” section.

Common side effects of Zemdri include the following:

• Decreased kidney function
• Diarrhea
• Changes in blood pressure
• Headache
• Nausea
• Vomiting

This is not a complete list of Zemdri side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been determined by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Zemdri including the following:

• A decline in kidney function. Toxicity from Zemdri may occur with kidney dysfunction. Your doctor may want to monitor your kidney functions with certain blood tests as well. Tell your healthcare provider right away if you have any of the following symptoms of kidney dysfunction:
  • swelling of face, ankles, hands, or feet
  • fatigue
  • paleness of skin
  • decreased urination
  • shortness of breath
  • change in blood pressures
• Ear toxicity. This has been mainly seen in patients with a family history of hearing loss, patients with kidney problems or patients getting higher doses or longer durations. Tell your healthcare provider right away if you have any of the following symptoms of ear toxicity:
  • hearing loss
  • ringing in the ears
  • feeling off balance
• Muscle weakness or paralysis. This mainly occured in patients with underlying neuromuscular disorders or those who were taking neuromuscular blocking drugs.
• Fetal harm. Patients who use Zemdri during pregnancy or become pregnancy during treatment should be informed of the potential harm to the fetus.
• Hypersensitivity reactions (severe allergic reaction). Tell your healthcare provider about any signs or symptoms of hypersensitivity, which include the following:
  • chest pain
  • swelling of the face, eyes, lips, tongue, arms, or legs
  • difficulty breathing or swallowing
  • rash
• Severe diarrhea. Taking antibacterial drugs can lead to overgrowth of bacteria in your colon which leads to severe diarrhea. Tell your healthcare provider if this happens to you.
• Drug-resistant bacteria. There is a chance that the medication will not work and cause the bacteria to be more drug resistant.

Do not take Zemdri if you:

• are allergic to Zemdri or to any of its ingredients
• are allergic to aminoglycoside antibiotics

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Zemdri, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Zemdri, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to aminoglycoside antibiotics
• are allergic to Zemdri or to any of its ingredients
• have neuromuscular problems
• have hearing problems
• have kidney problems
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

Based on studies of the same drug class, pregnant women had some babies born with problems. In animal studies, pregnant animals were given Zemdri and had babies born with problems as well. Therefore, the risks of taking Zemdri may outweigh the benefits to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Zemdri crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Zemdri.

Receive Zemdri exactly as prescribed.

Zemdri comes in an injectable form to be given directly into a vein by a healthcare professional.

Receive this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• your weight
• kidney function
• other medical conditions you have

The recommended dose of Zemdri for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, is 15 mg/kg every 24 hours for 4 to 7 days. This dose is for patients with a creatinine clearance (measure of kidney function) greater than or equal to 90 ml/min.

Dose adjustments are recommended for patients with kidney impairment.

If Zemdri is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

BOXED WARNINGS: NEPHROTOXICITY, OTOTOXICITY, NEUROMUSCULAR BLOCKADE AND FETAL HARM

• Nephrotoxicity has been reported with ZEMDRI. The risk of nephrotoxicity is greater in patients with impaired renal function, the elderly, and in those receiving concomitant nephrotoxic medications. Assess creatinine clearance in all patients prior to initiating therapy and daily during therapy. Therapeutic Drug Monitoring (TDM) is recommended for complicated urinary tract infection (cUTI) patients with CLcr less than 90 mL/min to avoid potentially toxic levels.
• Ototoxicity, manifested as hearing loss, tinnitus, and/or vertigo, has been reported with ZEMDRI. Symptoms of aminoglycoside-associated ototoxicity may be irreversible and may not become evident until after completion of therapy. Aminoglycoside-associated ototoxicity has been observed primarily in patients with a family history of hearing loss, patients with renal impairment, and in patients receiving higher doses and/or longer durations of therapy than recommended.
• Aminoglycosides have been associated with neuromuscular blockade. During therapy with ZEMDRI, monitor for adverse reactions associated with neuromuscular blockade particularly in high-risk patients, such as patients with underlying neuromuscular disorders (including myasthenia gravis) or in patients concomitantly receiving neuromuscular blocking agents.
• Aminoglycosides, including ZEMDRI, can cause fetal harm when administered to a pregnant woman.